Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-01-01 @ 5:12 AM
Study NCT ID:
NCT01561261
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2012-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Acute Compartment Syndrome (PACS)
Sponsor:
Major Extremity Trauma Research Consortium
Organization:
Study Overview
Official Title:
Predicting Acute Compartment Syndrome (PACS) Using Optimized Clinical Assessment, Continuous Pressure Monitoring, and Continuous Tissue Oximetry
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACS
Brief Summary:
The long-term objective is to develop a tool to aid in making a timely and accurate diagnosis of acute compartment syndrome (ACS).
The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).
Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:
* A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
* Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
The immediate objective is to develop a model to accurately predict the likelihood of ACS based on data available to the clinician within the first 48 hours of injury (specific clinical findings supplemented by muscle oxygenation measured by near-infrared spectroscopy (NIRS), and continuous intramuscular pressure (IMP) and perfusion pressure (PP) monitoring).
Our primary outcome is the retrospective assessment of the likelihood of compartment syndrome made by a panel of clinicians using the following data:
* A physiologic "fingerprint" composed of continuous pressure versus time curve, continuous oximetry values, response of muscle to fasciotomy when performed, and serum biomarkers of muscle injury (CPK levels).
* Clinical and functional outcomes at 6 months post-injury including: sensory exam, muscle function, presence/absence of myoneural deficit, and patient reported function using the Short Musculoskeletal Function Assessment (SMFA).
Detailed Description:
Specific Aim 1: Prospectively enroll and follow for 6 months a sample of 200 patients. Patients will receive continuous tissue perfusion monitoring using NIRS in all 4 leg compartments and intramuscular pressure (IMP) via indwelling catheters placed in the anterior and deep posterior compartments. These measures will be blinded and not provided in real time to treating physicians. All clinical care, including diagnosis of ACS, will be according to current standard-of-care practiced at each institution.
Specific Aim 2: Convene expert panels of 5 orthopaedic surgeons experienced in the diagnosis and treatment of ACS to retrospectively assess the likelihood that each patient had ACS. This retrospective assessment will be based on a 'patient profile' summarizing data collected as part of this study.
Specific Aim 3: Determine the extent to which clinicians agree in retrospective assessments of the likelihood of ACS.
Hypothesis: On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in \< 90% of cases.
Specific Aim 4: Model the panel's assessment of the likelihood of ACS as a function of data available to the clinician within the first 48 hours of injury using a training set of the data. This model can then be used to compute a point estimate of the risk of ACS (and associated 95% confidence interval) for any given patient.
Specific Aim 5: Assess, for patients in a test/validation data set, the performance of the model in predicting the panel's assessment of the likelihood of ACS.
Hypothesis: In \< 95% of the cases, the panel's assessment of the likelihood of ACS will fall within the 95% interval of uncertainty predicted by the model.
Specific Aim 2: Convene expert panels of 5 orthopaedic surgeons experienced in the diagnosis and treatment of ACS to retrospectively assess the likelihood that each patient had ACS. This retrospective assessment will be based on a 'patient profile' summarizing data collected as part of this study.
Specific Aim 3: Determine the extent to which clinicians agree in retrospective assessments of the likelihood of ACS.
Hypothesis: On the basis of known clinical and functional outcome at 6 months and monitoring information, clinicians will agree on the likelihood of ACS in \< 90% of cases.
Specific Aim 4: Model the panel's assessment of the likelihood of ACS as a function of data available to the clinician within the first 48 hours of injury using a training set of the data. This model can then be used to compute a point estimate of the risk of ACS (and associated 95% confidence interval) for any given patient.
Specific Aim 5: Assess, for patients in a test/validation data set, the performance of the model in predicting the panel's assessment of the likelihood of ACS.
Hypothesis: In \< 95% of the cases, the panel's assessment of the likelihood of ACS will fall within the 95% interval of uncertainty predicted by the model.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: